BR112017023001B1 - ADAPTER FOR A DRUG DELIVERY DEVICE AND DRUG DELIVERY DEVICE - Google Patents

Abstract

ADAPTER FOR A DRUG DELIVERY DEVICE AND DRUG DELIVERY DEVICE. The present invention relates to an adapter (30) for a drug delivery device with a reservoir (12) and a longitudinal tip (20), the adapter (30) comprising a distal portion defining a connecting ring (31). ) intended to receive a connector, and a proximal portion defining a mounting ring (33) having an inner surface (634), the mounting ring (33) is shaped and configured so that when the adapter (30) is mounted around the longitudinal tip (20) of the drug delivery device, at least one annular space (38) is created between said inner surface (34) of the mounting ring (33) and said outer surface (20a) of the tip longitudinal (20), the at least one annular space (38) being capable of accommodating an adhesive layer (40) so as to connect said adapter (30) to said longitudinal spike. The invention further relates to a drug delivery device comprising such an adapter.

Description

BACKGROUND OF THE INVENTION

[001] The present invention relates to an adapter, in particular a luer-type locking adapter for use with a drug delivery device having a reservoir and a longitudinal tip, the adapter being capable of being connected around the longitudinal tip. of the drug delivery device, so as to connect the drug delivery device with a connector, such as an injection needle or an intravenous line. The present invention also relates to a drug delivery device comprising such an adapter.

[002] In this patent application, the distal end of a component or apparatus is to be understood to mean the end furthest from the user's hand and the proximal end is to be understood to mean the end closest to the user's hand, with reference to the device of administration intended for use with said component or apparatus. As such, in this patent application, the distal direction is to be understood as the injection direction with reference to the drug delivery device, and the proximal direction is the direction opposite to said injection direction.

[003] Drug delivery devices are widely used by medical personnel and patients to store and/or administer and/or transfer the medicinal compositions such as drugs, vaccines, cosmetics or diagnostic liquids. They may take the form of a cartridge or a syringe, both types of devices comprising a reservoir for storing the medicinal composition. Drug delivery devices are preferably made of glass due to its high chemical passivity, low gas permeability and high transparency, which allows for prolonged storage and easy inspection. Drug delivery devices, such as syringes, comprise a longitudinal tip at their distal end (the end toward the injection, close to the patient's skin), the longitudinal tip having a longitudinal channel for dispensing any material stored in the reservoir. However, this longitudinal tip does not allow parenteral administration by itself and must include either a needle with base, or an adapter that allows connection of the syringe to a connector, such as a needle hub, or an intravenous (IV) line. . This adapter is a critical part for injection safety and must be reversibly attached to the connectors and irreversibly secured to the longitudinal tip of the syringe. In fact, it is essential for safety reasons that the adapter and connector are correctly and securely mounted together on the longitudinal tip of the syringe.

[004] The connection of the adapter to a connector is usually made by two cooperating wires, one located inside the adapter and the other located outside the proximal part of the connector, so that the needle or intravenous line can be screwed into the adapter. adapter before injection. However, screwing these two parts together often results in significant pull-out force between the tip and adapter, as some connectors apply pressure to the tip and back pressure to the adapter to achieve a tight seal. In addition, when a viscous drug is injected, an extraction force is created applied to the adapter since the inner diameter of the connector is smaller than the diameter of the longitudinal channel of the tip. Both phenomena can lead to disconnection of the adapter from the drug delivery device, which can affect the safety of the patient and medical staff.

[005] Finally, the secure screwing of the connector usually results in applying significant torque to the connector, the torque being transmitted to the adapter; resulting in the risk of the adapter ends turning around the longitudinal tip. This can prevent a secure connection of the connector to the adapter, as it becomes difficult to ensure that the connector is fully screwed into the adapter. Consequently, the connection between the adapter and the longitudinal tip of the syringe has to resist against the pull-out force as well as against the torque applied at the time of connection with a connector and/or at the time of injection. Indeed, extracting the adapter from the syringe tip can result in leakage of the expensive medicinal composition, but also for an inaccurate injection dose or, in extreme cases, the projection of the drug or projection of the injection needle. In addition, rotation of the adapter relative to the longitudinal tip can prevent optimal connection to the connector and therefore can also lead to needle tip leakage and/or injury, as already mentioned.

[006] Adapters for connecting a drug delivery device to a connector are well known. Such adapters are generally secured around the longitudinal tip of the syringe by snapping force or frictional force, for example by mechanical attachment means defined in the longitudinal tip, such as a groove or a ring. However, incorporating such attachment features into the longitudinal tip would require a complex molding tool in the case of a plastic drug delivery device or an additional forming step in the case of a glass drug delivery device, the which can be difficult to control. Furthermore, a modified longitudinal tip can be sensitive to failure and can potentially lead to tip breakage. Last but not least, an adapter connected around a longitudinal tip by snap fit or friction force often demonstrates limited torque resistance.

[007] There is, therefore, a need for an adapter that shows both an ideal pullout force and torque resistance. There is also a need for an adapter that can be mounted to a regular longitudinal spike without any other means of attachment. Finally, there is a need for a drug delivery device provided with this adapter. These needs are met by embodiments of the present invention.

BRIEF SUMMARY OF THE INVENTION

[008] One embodiment of the present invention is an adapter for a drug delivery device with a reservoir and a longitudinal tip, the longitudinal tip having an outer surface and a longitudinal channel for dispensing any material stored in the reservoir. The adapter comprises a distal portion defining a connection ring for receiving a connector, and a proximal portion defining a mounting ring having an inner surface. The mounting ring is shaped and configured so that when the adapter is mounted around the longitudinal tip of the drug delivery device, an annular space is created between said inner surface of the mounting ring and said outer surface of the tip. longitudinally, the annular space being further capable of accommodating an adhesive layer so as to connect said adapter to said longitudinal spike. An annular ring is provided at the distal end of the inner surface of the mounting ring.

[009] Due to the annular space being partially delimited by the annular ring, an adhesive layer introduced between the adapter and the longitudinal tip allows resistance to any torque force or thrust force submitted to the adapter during use. Furthermore, such an adapter can be irreversibly attached to a regular longitudinal point, which is a longitudinal point without any means of attachment, such as a groove or a ring.

[010] In particular, in the adapter of the invention, R1 being the radius of an inner diameter of the mounting ring and R2 being the radius of an inner diameter of the annular ring, R1 is greater than R2.

[011] One aspect of the invention is an adapter for a drug delivery device with a reservoir and a longitudinal tip, the tip having an outer surface and a longitudinal channel for dispensing any material stored in the reservoir, the adapter comprising a portion distal part defining a connecting ring intended to receive a connector, and a proximal part defining a mounting ring intended to be connected to the outer surface of the longitudinal tip, said mounting ring having an inner surface, wherein an annular ring is provided at a distal end of the inner surface of the mounting ring, where R1 is the radius of an inner diameter of the mounting ring and R2 is the radius of an inner diameter of the annular ring, Rl1 is greater than R2.

[012] The internal surface of the mounting ring and a proximal wall of the annular ring therefore define an internal annular recess of the mounting ring, said internal annular recess being open at its proximal end and closed at its distal end by the proximal wall of the ring ring. The inner annular recess has a radius R3 corresponding to R1 - R2.

[013] When the adapter of the invention is mounted around the longitudinal tip of the drug delivery device, the internal annular recess allows for the creation of an annular space between the internal surface of the mounting ring and the external surface of the longitudinal tip. As will be evident from the description below, the annular space may accommodate an adhesive layer so as to attach the adapter to the longitudinal tip. In embodiments, the inner surface of the mounting ring comprises at least one bulge so that when the adapter is mounted around the longitudinal tip of the drug delivery device, said at least one bulge projects into said at least an annular space.

[014] In a preferred embodiment, the inner surface of the mounting ring comprises protrusions such that, when the adapter is mounted around the longitudinal tip of the drug delivery device, the protuberances protrude into the annular space created between the mounting ring and the longitudinal tip. These protuberances may or may not contact the outer surface of the longitudinal tip and are intended to improve the annular space, in particular when it is accommodated with an adhesive layer. In particular, the protrusions are intended to optimize the internal structure of the internal annular recess and the annular space, creating within said internal annular recess and said annular space a series of partially separate volumes that communicate with each other, whereby each is capable of receiving part of the adhesive intended to form the adhesive layer.

[015] In embodiments, said at least one protuberance is chosen from at least one continuous longitudinal rib, at least one segmented rib, transverse segments, at least one diagonal rib, bulbs or cylinders, T-shaped or cross. The bulges can consist of a variety of shapes, such as continuous or segmented longitudinal ribs, transverse segments, diagonal ribs, bulbs or crosses, at least one bulge is required. The bulges create volumes that communicate with each other so that when a fluid adhesive is introduced into the annular space through the open proximal end of the inner annular recess, the adhesive flows and spreads to fill the multitude of volumes forming the space. cancel. When an adhesive layer is accommodated in the annular space, the continuous or segmented longitudinal ribs provide additional resistance to a torque applied to the adapter, while the transverse segments bring additional resistance to the pull-out force applied to the adapter. Diagonal ribs, bulbs and/or crosses put additional resistance to torque and thrust force.

[016] In embodiments, the inner surface of the mounting ring comprises protrusions in the form of longitudinal ribs. For example, the inner surface of the mounting ring comprises protrusions in the form of three longitudinal ribs that protrude from the inner surface of the mounting ring. The longitudinal ribs can be regularly placed along a circumference of the inner surface. The longitudinal ribs can extend the entire length of the mounting ring. In embodiments, the longitudinal ribs are continuous longitudinal ribs. In embodiments, the longitudinal ribs are segmented longitudinal ribs. The continuous or segmented longitudinal ribs can provide additional resistance to a torque applied to the adapter when the adapter is attached to the longitudinal tip of the drug delivery device.

[017] In embodiments, the inner surface of the mounting ring comprises protrusions in the form of transverse segments. The transverse segments may additionally resist an extraction force applied to the adapter when the adapter is attached to the longitudinal tip of the drug delivery device.

[018] In embodiments, the inner surface of the mounting ring comprises protrusions in the form of three diagonal ribs. In embodiments, the inner surface of the mounting ring comprises protrusions in the form of bulbs or cylinders. In embodiments, the inner surface of the mounting ring comprises T-shaped or cross-shaped protrusions.

[019] The annular ring is useful to prevent the adhesive from reaching the distal part of the longitudinal tip, which remains clean for future medical use. In addition, the annular ring may be useful as a centering means when mounting the adapter of the present invention to the longitudinal tip of a drug delivery device.

[020] In embodiments, where R1 is the radius of an inner diameter of the mounting ring and R2 is the radius of an inner diameter of the annular ring, R1 is greater than R2, the inner surface of the mounting ring and a proximal wall of the annular ring defines an inner annular recess of the mounting ring, said inner annular recess being open at its proximal end and closed at its distal end by the proximal wall of the annular ring, said inner annular recess having a corresponding radius R3 to R1-R2, wherein R3 ranges from 0.3 to 0.5 mm.

[021] In embodiments where the inner surface of the mounting ring comprises protuberances, the protuberances protrude into said inner annular recess of said mounting ring.

[022] The adapter is preferably made from a single piece of material to ensure optimum strength. Hard plastic can be a material of choice for the same reason. Optionally, the adapter can be made of a light transmitting material to allow detection of leaks and/or weak connections when a connector is attached to the adapter.

[023] Another embodiment of the present invention is a drug delivery device comprising a reservoir for storing a material to be dispensed and a longitudinal tip with a longitudinal channel for dispensing any material stored in the reservoir. The drug delivery device further comprises an adapter mounted around the longitudinal tip to permit connection of a connector with the longitudinal channel, the adapter being attached to the longitudinal tip by an adhesive layer. This adhesive layer brings significant improvements when compared to prior art adapters. In particular, it makes it possible to achieve a high resistance to the torque and pullout force applied to the adapter. Furthermore, an irreversible attachment of the adapter to the longitudinal tip of the drug delivery device can be achieved without the need for other attachment means. This avoids an additional manufacturing step in creating attachment means and prevents weakening of the longitudinal tip, particularly when the drug delivery device is made of glass.

[024] When the inner surface of the adapter mounting ring encompasses protrusions, these protrusions optimize the adhesion strength of the adhesive layer for improved pull-out and/or torque resistance. The homogeneity of the adhesive layer can also be optimized due to these bulges.

[025] Prior to use, a drug delivery device provided with an adapter in accordance with the present invention may be closed by a spiked cap to prevent stored material from escaping the reservoir during storage and transport. Examples of such tip caps are described in international application WO2015055608 and European patent EP1192965. Preferably, a drug delivery device closed by such a tip cap may have evidence of prior use means to make visible whether such drug delivery device has already been opened and is not safe for injection. Such evidence of pre-use means may comprise a shrinkable film, as disclosed in international application WO2010064074, or breakable tabs between the tip cap and adapter.

[026] The adapter attached to the longitudinal tip of the drug delivery device shows significant resistance to torque and pullout force that can be applied during handling and/or use.

[027] Other advantageous embodiments of the present invention are described below.

BRIEF DESCRIPTION OF THE DRAWINGS

[028] Figure 1 depicts a drug delivery device in accordance with the present invention.

[029] Figure 2 is an enlarged view of the longitudinal tip of a drug delivery device according to Figure 1.

[030] Figure 3 depicts a cross-sectional view of an adapter according to an embodiment of the present invention.

[031] Figure 4 reveals a rear view of the adapter in Figure 3.

[032] Figure 5 reveals a perspective rear view of the adapter of Figure 3.

[033] Figure 6 is a cross-sectional view of the adapter of Figure 3 when mounted on a longitudinal end of a drug delivery device.

[034] Figure 7 is a cross-sectional view of the adapter of Figure 6 along the l-I' plane.

[035] Figures 8A to 8C are cross-sectional views of different examples of the adapter of Figure 3 mounted on the longitudinal tip of the drug delivery device of Figure 2.

[036] Figure 9 is a cross-sectional view of the adapter of Figure 3 attached to the longitudinal tip of a drug delivery device.

[037] Figure 10 is a cross-sectional view of the adapter of Figure 9 along the plane II-II'.

[038] Figures 11A-11F are the flat projections of the inner surface of adapter mounting rings according to different embodiments of the adapter of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[039] Figure 1 depicts an example of a drug delivery device 10 in accordance with the present invention. Drug delivery device 10 has a longitudinal axis A and comprises a longitudinal barrel 11 that defines a reservoir 12, the longitudinal barrel 11 has an open proximal end that defines a flange 13 and a constrained distal end that defines a longitudinal tip 20 with a longitudinal channel 21. The boundary between the longitudinal point 20 and the barrel 11 defines a shoulder 14. An adapter 130 with a longitudinal axis B and an annular ring 136 is mounted around the longitudinal point 20 such that a space annular 138 is created between the adapter 130 and the longitudinal point 20. In addition, an adhesive layer 40 is housed in the annular space 138 in order to connect the adapter 130 to the longitudinal point 20. Referring to Figure 1, when the adapter 130 is attached to the longitudinal tip 20, the longitudinal axis B of the adapter 130 is aligned with the longitudinal axis A of the drug delivery device 10.

[040] Referring to Figure 2, the longitudinal tip 20 of the drug delivery device 10 has an outer surface 20a and a generally conical shape. More precisely, it comprises a cylindrical part 22, located next to a conical part 23. The longitudinal tip 20 defines a distal surface 24 which can be flat, chamfered or curved. In another embodiment (as shown in Figure 8C), the longitudinal tip 20 comprises only a conical part 23 without any cylindrical part 22.

[041] An adapter 130 according to a first embodiment of the present invention is disclosed in Figures 3 to 5.

[042] The adapter 130 comprises a distal portion 130a, which defines a connecting ring 131 that has an inner surface 132. The inner surface 132 is provided with a screw 132a as a connecting element capable of connecting a connector (not shown) , such as a needle or an intravenous line. Alternatively, these connecting elements may be a bayonet system or a mortise system (not shown). The distal end of the connecting ring 131 defines the distal end 130c of the adapter 130.

[043] The adapter 130 further comprises a proximal portion 130b with a mounting ring 133 that defines an inner surface 134. The inner surface 134 of the mounting ring 133 of the adapter 130 is provided with protuberances in the form of three longitudinal ribs 135 that intersect. project from the inner surface 134 of the mounting ring 133 (only one is visible in Figure 3). Preferably, the longitudinal ribs 135 are evenly placed along a circumference of the inner surface 134. Preferably, the longitudinal ribs 135 extend the entire length of the mounting ring 133. In the example shown, the longitudinal ribs 135 are ribs. continuous longitudinal.

[044] Additionally, an annular ring 136 is further defined at the distal end of the inner surface 134, at the boundary between the mounting ring 133 and the connecting ring 131. In Figures 3 to 5, said annular ring 136 comes into contact with the longitudinal ribs 135, however, in other examples, the longitudinal ribs 135 may be closely spaced from the annular ring 136.

[045] Referring to Figure 3, the radius R1 of an inner diameter of the mounting ring 133 and the radius R2 of an inner diameter of the annular ring 136 are shown. As it appears from this figure, R1 is greater than R2.

[046] Referring to Figures 3-5, the inner surface 134 of the mounting ring 133 and a proximal wall 136a of the annular ring 136 therefore define an inner annular recess 140 of the mounting ring 133, the inner annular recess being 140 is open at its proximal end and closed at its distal end by proximal wall 136a of annular ring 136. Inner annular recess 140 has a radius R3 corresponding to R1-R2.

[047] In embodiments, R3 ranges from 0.3 to 0.5 mm.

[048] Referring to Figures 3-5, the longitudinal ribs 135 protrude into the inner annular recess 140.

[049] On its external surface, the adapter 130 can have an embossed design, showing, for example, more or less thick longitudinal projections 137 (see Figure 5) to facilitate, for example, its attachment. The longitudinal projections 137 on the outer surface of the adapter, as shown in Figure 5, are an example of an embossed design intended to provide easy manipulation of the adapter 130 by the user when a connector is about to be screwed into the drug delivery device. of the present invention, even with wet gloves or hands.

[050] Adapter 130 can be made of any rigid polymer adapted for medical use, such as high density polyethylene (PE), polypropylene (PP), polycarbonate (PC), acrylonitrile butadiene styrene (ABS), polyoxymethylene (POM), polystyrene (PS), polybutylene terephthalate (PBT), polyamide (PA) and combinations thereof. To simplify its manufacture, the adapter 130 preferably consists of a single piece of material, preferably of a light transmitting material.

[051] Adapter 130 is intended to be mounted on the longitudinal tip 20 of a drug delivery device 10 such that the distal surface 24 of said drug delivery device 10 extends further out of the connecting ring 131 in the distal direction, in particular from a distance P (see Figures 6 and 9). As illustrated in Figures 6, 7 and 8A-8C, mounting ring 133 is shaped and configured to create an annular space 138 between inner surface 134 of mounting ring 133 and outer surface 20a of longitudinal spike 20. This annular space 138 is capable of accommodating an adhesive layer 40 in order to irreversibly bond the adapter 130 to the longitudinal tip 20. In particular, the internal annular recess 140 of the mounting ring 133 allows the creation of said annular space 138.

[052] In Figure 8A, the mounting ring 33 is mounted on the cylindrical part 22 of the tip 20, with the conical part 23 of the conical tip available for any connection. The longitudinal ribs 135 and the annular ring 136 may or may not be in contact with the outer surface 20a of the longitudinal point 20. Preferably, at least one of the longitudinal ribs 135 or the annular ring 136 is in contact with the outer surface 20a of the point. 20. If necessary, at least one of the longitudinal ribs 135 or the annular ring 136 can show an interference fit with the outer surface 20a of the longitudinal stub 20. For example, in Figure 6, the interference fit between the annular ring 136 and the outer surface 20a of the longitudinal stub 20 is shown in Figures 6 and 7 as an annular ring overlapping OV on the longitudinal stub 20. This interference fit can be useful for a friction force pre-assembly of the adapter 130 on the stub. 20 prior to irreversible bonding with an adhesive layer 40. As seen from Figure 7, an overlapping OV between the longitudinal ribs 135 and the outer surface 20a of the long tip Itudinal 20 is visible and can also be useful for pre-assembling the friction force. As illustrated in Figure 7, the longitudinal ribs 135 segment the inner annular recess 140 and the longitudinal ribs 135, thereby segmenting the annular space 138 into three cavities (138a, 138b, 138c), each cavity having a proximal opening and being closed by two longitudinal ribs 135 and a part of the annular rib 136.

[053] Alternatively, the mounting ring 133 of the adapter 130 can be mounted on the cylindrical part 22 and the conical part 23 of the longitudinal tip 20. As is visible in Figure 8B, the longitudinal ribs 135 may confront or contact the part. 22 while the annular ring 136 may confront or contact the conical part 23 of the longitudinal tip 20. In this Figure 8B, the annular ring 136 and the longitudinal ribs 135 do not contact each other and are separated by a void VS. Such a configuration can be useful for expanding the area of annular space 138 in which the adhesive layer 40 is intended to be accommodated. In other words, with this configuration, an adhesive layer 40 with a larger area can be accommodated between the outer surface 20a of the longitudinal tip 20 and the inner surface 134 of the mounting ring 133, compared to the example in Figure 8A. Preferably, the inner surface 134 of the mounting ring 133 is substantially parallel to the outer surface 20a of the longitudinal spike 20, so as to create an annular space 138 with a constant thickness (t), as seen in Figures 8A and 8B. In cases where the inner surface 134 of the mounting ring 133 is substantially parallel to the outer surface 20a of the longitudinal spike 20 and the annular space 138 has a constant thickness (t), the volume of the annular space 138 can be substantially equal to the volume of the inner annular recess 140.

[054] In another alternative shown in Figure 8C, the longitudinal tip 20 is not provided with a cylindrical part 22 but only with a conical part 23. In this example, the inner surface 134 of the mounting ring 133 has a straight profile while the surface 20a of the longitudinal tip 20 has an inclined profile, thus creating an annular space 138 with a progressive thickness (t'). In this case, the volume of the annular space 138 can be substantially less than the volume of the inner annular recess 140 of the mounting ring 133.

[055] For example, to join the adapter 130 to the longitudinal tip 20, an adhesive is introduced into the annular space 138. Due to the longitudinal ribs 135, the adhesive is distributed homogeneously in the annular space 138 to form a uniform adhesive layer 40 (see Figures). 9 and 10) segmented by said longitudinal ribs 135. The annular ring 136 can act as a barrier to the adhesive as it prevents the adhesive from reaching the distal part of the longitudinal tip 20 which therefore remains clean for later medical use. Adhesive may be distributed on adapter 130, before or after the adapter being positioned around longitudinal tip 20.

[056] The adhesive can be any material adapted to join parts in the medical field. In particular, the adhesive can be chosen from a hot melt adhesive and glue, for example glue with an acrylate base. The bonding area can be between 20 and 40 mm 2 and the thickness of the adhesive layer 40 can be between 0.3 and 0.5 mm.

[057] The adhesive may be cured by any method adapted to form an adhesive layer 40 (see Figure 9-10) permanently bonded to the outer surface 20a of the longitudinal tip 20 and to the inner surface 134 of the adapter 130. The method of curing may be selected according to the specific type of adhesive used and can be chosen from gamma irradiation, UV irradiation, heat curing, cooling or drying and the like. Prior to this curing step, the interference fit between the outer surface 20a of the longitudinal spike 20 and the annular ring 136 and/or the longitudinal ribs 135 may be useful to temporarily hold the adapter 130 on the longitudinal spike 120 in the correct position, preventing thus any disconnection due to vibrations generated by the assembly process.

[058] At the end of this assembly process, the adapter 130 is irreversibly attached to the longitudinal tip 120 of a drug delivery device 110 by an adhesive layer 40 housed in an annular space 138, as shown in Figures 9 and 10. Because of this adhesive layer 40, adapter 130 can be attached around longitudinal tip 20 without any need for a shoulder or ring on outer surface 20a of longitudinal tip 20, as would normally be required by prior art adapters. This greatly simplifies the manufacturing process of a drug delivery device, especially for drug delivery devices made of glass. Furthermore, the chemical bond obtained with the presence of the adhesive layer 40 makes it possible to achieve a resistance superior to the torque and pullout force that is usually applied to the adapter 130 when a connector is connected to the connection ring 131 of the adapter 130 .

[059] Referring to Figure 10, the adhesive layer 40 is segmented by the longitudinal ribs 135 into three parts (40a, 40b, 40c), which allows for significant torque resistance applied when a connector is connected to the drug delivery device. 10 through adapter 130. When this torque is applied, longitudinal ribs 135 reduce the shear stress between the adhesive and either the outer surface 20a of the longitudinal tip 120 or the inner surface 134 of the mounting ring 133 of the adapter 130. longitudinal ribs 135 thus function as mechanical stops blocking any potential rotational movement of the adapter 130 against the adhesive layer 40, which contributes to increasing the torque resistance of an adapter 130 attached to the longitudinal tip 20 of a drug delivery device 10 per a layer of adhesive 40.

[060] In other embodiments, the protuberances may adopt other shapes to achieve different technical effects. Figure 11A depicts the planar projection of the inner surface 134 of the mount 133 of the adapter 130, in accordance with the first embodiment of the present invention (Figures 3-5) being provided by reference.

[061] Figure 11B shows the flat projection of the inner surface 234 of the mounting ring 233 of an adapter 230 in accordance with another embodiment of the present invention. This adapter 230 is similar to the adapter 130 described above except that the inner surface 234 comprises protrusions in the form of segmented longitudinal ribs 235. These protuberances 235 can be useful to improve the homogeneity of the adhesive layer 40 in the second step of the process. connection, as described above. As illustrated in Figure 11B, an annular ring 236 is provided at the distal end of the inner surface 234 of the mounting ring 233.

[062] Figure 11C depicts the planar projection of the inner surface 334 of the mounting ring 333 of an adapter 330 in accordance with another embodiment of the present invention. This adapter 330 is similar to the adapter 130 described above, but differs in that the inner surface 334 is provided with protuberances in the form of transverse segments 335. Such protrusions 335 can be useful in reducing the shear stress between the adhesive and the surface. internal surface 334 or the external surface 20a of the longitudinal tip 20 when the adapter 330 is subjected to a pulling force, for example when a connector is connected to the connecting ring 331. When the adapter 330 is mounted on the longitudinal tip 20 of a drug delivery 10 by an adhesive layer 40, the transverse segments 335 can therefore function as mechanical stops blocking any potential pull-out movement of the adapter 330 against the adhesive layer 40 which contributes to increasing the pull-out resistance of the adapter 330. As illustrated in Figure 11C, an annular ring 336 is provided at the distal end of the inner surface 334 of the ring. mount 333.

[063] Figure 11D depicts the planar projection of the inner surface 434 of the mounting ring 433 of an adapter 430 in accordance with another embodiment of the present invention. This adapter 430 is similar to the adapter 130 described above, but different in that the inner surface 434 is provided with protuberances in the form of three diagonal ribs 435, at least one diagonal rib 435 being required. Due to its diagonal positioning, such protuberances 435 can be useful in providing a mechanical stop lock, blocking both extraction movements and torque when adapter 430 is attached by an adhesive layer 40 to the longitudinal tip 20 of a drug delivery device 10. Such protuberances 435 also can help to obtain a homogeneous adhesive layer 40, for example, by rotating the adapter 430 during the introduction of the adhesive in the second stage of the assembly process described above. As illustrated in Figure 11D, an annular ring 436 is provided at the distal end of the inner surface 434 of the mounting ring 433.

[064] Figure 11E is the planar projection of the inner surface 534 of the mounting ring 533 of an adapter 530 in accordance with another embodiment of the present invention. This adapter 530 is similar to the adapter 130 described above, but differs in that the inner surface 534 is provided with protuberances in the form of bulbs or cylinders 535. Similar to the diagonal ribs 435, the bulbs 535 can be useful in providing a mechanical stop blocking the extraction movements and torque when the adapter 530 is attached by an adhesive layer 40 to the longitudinal tip 20 of a drug delivery device 10. Such protuberances 535 can also help to obtain a homogeneous adhesive layer 40, for example dispensing the adhesive by percolation into the annular space 438 in the second step of the aforementioned process. As illustrated in Figure 11E, an annular ring 536 is provided at the distal end of the inner surface 534 of the mounting ring 533.

[065] Figure 11F is the flat projection of the inner surface 634 of the mounting ring 633 of an adapter 630 in accordance with another embodiment of the present invention. This adapter 630 is similar to the adapter 130 described above, but differs in that the inner surface 634 is provided with T-shaped protuberances or crosses 635. Similar to the diagonal ribs 435 and bulbs 535, the crosses 635 may be useful for providing a mechanical stop to block both extraction movements and torque when adapter 630 is attached by an adhesive layer 40 to the longitudinal tip 20 of a drug delivery device 10. As illustrated in Figure 11F, an annular ring 636 is provided. at the distal end of the inner surface 634 of the mounting ring 633.

[066] In the embodiment of Figures 11B to 11F, the protuberances (235, 335, 435, 535, 635) protrude in the respective corresponding annular space created between the inner surfaces (234, 334, 434, 534, 634) and the outer surface of the longitudinal spike and may or may not contact the outer surface 20a of the longitudinal spike 20, when corresponding adapters (230, 330, 430, 530, 630) are attached to the longitudinal spike 20 of a drug delivery device 10. Furthermore, these embodiments are provided with an annular rib similar to the annular rib 136 of the adapter 130. As applicable, all individual features that are shown in the individual embodiments can be combined and/or interchanged with each other without depart from the scope of the invention.

[067] The annular space created between the adapter mounting ring and the outer surface 20a of the longitudinal tip 20 can thus be optimized by protrusions to provide additional pull-out/or torque resistance of the adhesive layer 40. In addition, some protrusions also can help maintain the homogeneity of the adhesive layer 40, thus preventing the weakening of the adhesive layer 40.

[068] Furthermore, with the adapters according to the aforementioned embodiments, the longitudinal tip 20 of the drug delivery device 10 is not required to define other connecting means such as an annular groove or a ring, which can be difficult to manufacture, particularly in the case of drug delivery devices made of glass. Finally, as the glass forming process can lead to important dimensional tolerances, specifically in the shoulder 14 between the longitudinal cylinder 11 and the longitudinal point 20, it is particularly critical that the adapter is exclusively connected around the longitudinal point 20, without any contact. directly with the longitudinal cylinder 11 of the drug delivery device 10.

Claims (15)

1. Adapter (130, 230, 330, 430, 530, 630) for a drug delivery device (10) with a reservoir (12) and a longitudinal tip (20), wherein the tip (20) has a surface (20a) and a longitudinal channel (21) for dispensing any material stored in the reservoir (12), the adapter (130, 230, 330, 430, 530, 630) comprises a distal portion (130a, 230a, 330a, 430a, 530a, 630a) defining a connecting ring (131) for receiving a connector, and a proximal portion (130b, 230b, 330b, 430b, 530b, 630b) defining a mounting ring (133, 233, 433, 533, 633) having an inner surface (134, 234, 334, 434, 534, 634), the mounting ring (133, 233, 433, 533, 633) is shaped and configured so that when the adapter (130, 230, 330, 430, 530, 630) is mounted around the longitudinal tip (20) of the drug delivery device (10), at least one annular space (138) is created between said inner surface (134, 234, 334, 434, 534, 634) of the year mounting element (133, 233, 433, 533, 633) and said outer surface (20a) of the longitudinal tip (20), the at least one annular space (138) being capable of accommodating an adhesive layer (40) so connecting said adapter (130, 230, 330, 430, 530, 630) to said longitudinal spike (20), CHARACTERIZED in that an annular ring (136, 236, 336, 436, 536, 636) is provided on the distal end of the inner surface (134, 234, 334, 434, 534, 634) of the mounting ring. 2. Adapter (130) according to claim 1, CHARACTERIZED in that the inner surface (134, 234, 334, 434, 534, 634) of the mounting ring (133, 233, 433, 533, 633) comprises at least one protrusion (135, 235, 335, 435, 535, 635) so that when the adapter (130, 230, 330, 430, 530) is mounted around the longitudinal tip (20) of the delivery device drug (10), at least one protuberance (135, 235, 335, 435, 535, 635) protrudes in said at least one annular space (138). 3. Adapter (130) according to claim 2, CHARACTERIZED in that said at least one protrusion is chosen from at least one continuous longitudinal rib (135), at least one segmented rib (235), transverse segments (335) ), at least one diagonal rib (435), bulbs or cylinders (535), a T-shape or crosses (635). 4. Adapter (130, 230) according to claim 2 or 3, CHARACTERIZED by the fact that the inner surface (134, 234) of the mounting ring (133, 233) comprises protrusions in the form of longitudinal ribs. 5. Adapter (130, 230) according to any one of claims 2 to 4, CHARACTERIZED by the fact that the inner surface (134, 234) of the mounting ring (133, 233) comprises protuberances in the form of three longitudinal ribs ( 135, 235) projecting from the inner surface (134, 234) of the mounting ring (133, 134). 6. Adapter (130, 230) according to claim 5, CHARACTERIZED in that the longitudinal ribs (135, 235) are placed regularly along a circumference of the inner surface (134, 234). 7. Adapter (103) according to any one of claims 1 to 6, CHARACTERIZED by the fact that R1 is the radius of an inner diameter of the mounting ring and R2 is the radius of an inner diameter of the annular ring, where R1 is greater than R2, the inner surface of the mounting ring and a proximal wall of the annular ring define an inner annular recess of the mounting ring, said inner annular recess being open at its proximal end and closed at its distal end by the proximal wall of the annular ring, said inner annular recess has a radius R3 corresponding to R1-R2, wherein R3 varies from 0.3 to 0.5 mm. 8. Drug delivery device (10) CHARACTERIZED in that it comprises an adapter (130, 230, 330, 430, 530, 630) as defined in any one of the preceding claims. 9. Drug delivery device (10) according to claim 8, CHARACTERIZED by the fact that the adapter (130, 230, 330, 430, 530, 630) is irreversibly connected to the longitudinal tip (20) by a adhesive layer (40) housed in the annular space (138). 10. Drug delivery device (10) according to claim 9, CHARACTERIZED in that the adhesive layer (40) has a thickness of at least 0.3 mm. 11. Drug delivery device (10) according to claims 9 or 10, CHARACTERIZED in that said adhesive layer (40) covers an area of at least 20 mm2 of the external surface (20a). 12. Drug delivery device, according to claims 2 and 9, CHARACTERIZED in that said at least one protuberance (135, 235, 335, 435, 535, 635) projects on said adhesive layer (40) . 13. Drug delivery device according to any one of claims 8 to 12, CHARACTERIZED in that the longitudinal tip (20) does not have any mechanical attachment means such as an annular shoulder or a ring. 14. Drug delivery device, according to any one of claims 9 to 13, CHARACTERIZED by the fact that the adapter (30) is exclusively attached to the drug delivery device (10) by the adhesive layer (40). 15. Drug delivery device, according to any one of claims 8 to 14, CHARACTERIZED by the fact that the longitudinal tip (20) is made of glass.

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